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Seamless, Adaptive, Phase2b/3, Double-blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirhosis

This trial will evaluate the study drug Belapectin in patients with NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. The purpose of this voluntary research study is to find out about the safety and efficacy of the study drug and for the prevention of esophageal varices in NASH Cirrhosis..

If you consent to participate, you will be asked to have some screening tests and procedures, as described in the table below. This period of up to 3 visits within 2 months is called Screening Period. Based upon results of tests and procedures completed during these visits, your study doctorwill be able to decide if you meet the requirements to participate in this study. If you meet the study requirements to participate in this study, your study doctor will discuss with you when you should start the study treatment.

Yes
 
Jonathan Stine
Nataliya Smith - at nsmith9@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04365868
STUDY00018518
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Inclusion Criteria:
Adults age >18-75 years old
early stage cirrhosis
diagnosis of NASH
Exclusion Criteria:
end stage cirrhosis
substance abuse
other liver disease
history of organ transplant
Digestive Systems & Liver Disease
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,